Impact of CardiolRxTM on Recurrent Pericarditis (MAvERIC-Pilot)

Inclusion Criteria

• Male or female 18 years of age or older
• Diagnosis of at least two episodes of recurrent pericarditis*,
• At least 1 day with pericarditis pain ≥4 on the 11-point Numerical Rating Scale (NRS) within prior 7 days
• One of;
• C-Reactive Protein** (CRP) level ≥1.0 mg/dL within prior 7 days OR
• Evidence of pericardial inflammation assessed by delayed pericardial hyperenhancement on cardiac magnetic resonance imaging (CMR)
• Currently receiving non-steroidal anti-inflammatory drugs (NSAIDs) and/or colchicine and/or corticosteroids (in any combination) for treatment of pericarditis in stable doses
• Male patients with partners of childbearing potential who have had a vasectomy or are willing to use double barrier contraception methods during the conduct of the study and for 2 months after the last dose of study drug.
• Women of childbearing potential willing to use an acceptable method of contraception starting with study drug administration and for a minimum of 2 months after study completion. Otherwise, women must be postmenopausal (at least 1 y absence of vaginal bleeding or spotting and confirmed by follicle stimulating hormone [FSH] ≥40 mIU/mL [or ≥ 40 IU/L] if less than 2 y postmenopausal) or be surgically sterile.
• Diagnosis of pericarditis according to the 2015 European Society of Cardiology (ESC) Guidelines for the Diagnosis and Management of Pericardial Diseases (Adler et al. 2015):

At least two of:

• Pericarditic chest pain
• Pericardial rub
• New widespread ST-segment elevation or PR-segment depression according to electrocardiogram (ECG) findings
• Pericardial effusion (new or worsening)
• Conversion: 1 mg/dL CRP = 10 mg/L hs-CRP

Exclusion Criteria

• Diagnosis of pericarditis that is secondary to specific prohibited etiologies, including tuberculosis (TB); neoplastic, purulent, or radiation etiologies; post-thoracic blunt trauma (e.g., motor vehicle accident); myocarditis
• Estimated glomerular filtration rate (eGFR) 5 times the upper limit of normal (ULN) or ALT or AST >3x ULN plus bilirubin >2x ULN
• Sepsis, defined as documented bacteremia at the time of screening or other documented active infection
• Prior history of sustained ventricular arrhythmia
• History of QT interval prolongation
• QTc interval > 500 msec
• Current participation in any research study involving investigational drugs or device
• Inability or unwillingness to give informed consent
• Ongoing drug or alcohol abuse
• On any cannabinoid during the past month
• Women who are pregnant or breastfeeding
• Current diagnosis of cancer, with the exception of non-melanoma skin cancer
• Any factor, which would make it unlikely that the patient can comply with the study procedures
• Showing suicidal tendency as per the Columbia Suicide Severity Rating Scale (C-SSRS), administered at screening
• On digoxin and/or type 1 or 3 antiarrhythmics
• On immunosuppressive therapy with any of the following:
• Rilonacept
• Anakinra
• Canakinumab
• Methotrexate
• Azathioprine
• Cyclosporine
• Intravenous immune globulin (IVIG)